A Survey of Attitudes of Experienced Blood Donors

February 21, 2019 updated by: Christopher R. France, Ph.D., Ohio University
This study examines the effects of a web-based motivational interview on 1) internal motivation to donate blood; 2) donor autonomy, competence and relatedness; and 3) donation intention and behavior. The study also evaluates whether group differences in donation intention and behavior are mediated by autonomy, competence, and relatedness, and in turn, internal motivation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Voluntary blood donation is both important and necessary for the provision of a steady and safe blood supply. With an aging population and increased restrictions on who can donate blood, maintenance of a stable blood supply is essential. Although 38% of the United States population is eligible to donate, only 5% actually does so. Retention of donors is essential to assuring the continuity of a safe blood supply; repeat donors are safer, more cost effective, and less likely to experience adverse reactions. Current recruitment and retention methods may not be sufficient to encourage repeat donations. According to Self-Determination Theory, people are more likely to persist with behaviors that are internally versus externally motivated. Internal motivation is enhanced by supporting an individual's needs for autonomy, competence, and relatedness. One intervention that has shown early promise as a novel method to enhance internal motivation to donate blood is motivational interviewing. However, implementation of a motivational interviewing intervention is costly and time consuming. Given the time and money required for training and delivery of a motivational interviewing intervention, the current study is designed to test the efficacy of a newly-developed web-based version of a motivational interview. Participants will be randomly assigned to complete either an on-line motivational interview about their blood donation experience or an on-line knowledge interview about blood donation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1177

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Athens, Ohio, United States, 45701
        • Ohio University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject donated blood within the last week with New York Blood Center.
  • Subject has made 2 or more blood donations.
  • Subject is eligible to donate blood again.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Motivational Interview
Complete an on-line motivational interview regarding participants' blood donation experience.
Behavioral: Motivational Interview
A web-based computer-tailored intervention that includes open-ended questions, reflective responses, affirmations, and summarizing, as well as informing and advising. Specific topics include 1) individual motivations for giving, 2) the relationship between past donation behavior and the individual's personal goals/values, 3) donation importance and confidence rulers, 4) addressing donor concerns, and 5) summarizing.
Placebo Comparator: Knowledge Interview
Complete an on-line interview regarding participants' general knowledge about blood donation.
Behavioral: Knowledge Interview
A web-based interview that includes open-ended questions regarding blood donation knowledge.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood donation attempts
Time Frame: 60 weeks after index donation
The number of blood donation attempts since their study participation will be obtained from the participants' donor records.
60 weeks after index donation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Donation Intention
Time Frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Intent to donate blood within the next 8 weeks will be assessed using three questions on a 7-point Likert-type scale, from 1 (disagree) to 7 (agree): I plan to donate blood in the next 8 weeks., How likely is it that you will donate blood in the next 8 weeks? and I will donate blood in the next 8 weeks. Total scores on the scale range from 3 to 21, with higher scores indicating greater intention to donate.
on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Donation Attitude
Time Frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Attitudes toward blood donation will be assessed using a 6-item measure where individuals are asked to rate how donating blood in the next 8 weeks would seem using a 7-item Likert-type scale. The scale distinguishes between cognitive attitudes (evaluative judgments: useful versus useless, pointless versus worthwhile, the wrong thing to do versus the right thing to do) and affective attitudes (emotional reactions: unpleasant versus pleasant, unenjoyable versus enjoyable, frightening versus not frightening). Total scores on the scale range from 6 to 42, with higher scores reflecting more positive attitudes toward blood donation.
on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Donation Perceived Behavioral Control
Time Frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Individuals' perception of control over their ability to donate blood will be assessed using a 6-item measure that assesses two components of perceived behavioral control: self-efficacy (three items) and controllability (three items). Items on the self-efficacy sub-scale ask about how confident the participant is in their ability to donate blood in the next 8 weeks, while the controllability sub-scale assesses how much control participants feel they have over whether or not they donate blood. Participants are asked to rate each item on a 7-point Likert-type scale. Total scores on the scale range from 6 to 42, with higher scores reflecting greater perception of control over ones ability to donate blood.
on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Donation Subjective Norms
Time Frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Individuals' perception about subjective norms will be assessed using a six item, 7-point Likert-type scale, with anchors at 1 (disagree/unlikely) and 7 (agree/likely). Total scores on the scale range from 6 to 42. The measure assesses both descriptive norms (perceived behavior of others) and injunctive norms (what an individual believes others want from him/her).
on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Blood Donor Identity
Time Frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Blood Donor Identity will be measured using an 18-item scale that examines an individual's motivation to donate on the six motivational factors proposed by Self Determination Theory: amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic regulation. Participants are asked to rate their agreement with each item on a 7-point Likert-type scale, with individual item scores ranging from 1 (not at all true) to 7 (very true). A composite score for the total scale is calculated by combining the six subscale scores using the weighting of -3, -2, -1, +1, +2, +3 for the amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic regulation subscales, respectively, in order to produce a single Relative Autonomy Index score.
on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Blood Donation Anxiety
Time Frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Anxiety will be assessed using the Blood Donor Anxiety Scale, a six-item scale that assesses for both the presence (3 items) and absence (3 items) of anxiety. Participants rate their agreement on how relaxed, content, pleasant, tense, nervous and jittery they would feel if they donated blood on a 4-point scale, with anchors at 1 (not at all) and 4 (very much). Composite scores on the scale range from 3 to 12, with higher scores on the presence subscale reflecting more anxiety, and higher scores on the absence subscale reflecting less anxiety about a future donation.
on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Blood Donor Ambivalence
Time Frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
The 6-item ambivalence scale asks participants to rate how true a statement is for them on a 7-point scale (1=Not at all true to 7=Very true). Separate subscale scores are calculated for commitment and indecision (scores ranging from 3 to 21 for each subscale).
on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Psychological Need Support
Time Frame: on average 2 days after interview
To assess whether the Motivational Interview intervention supported the basic psychological needs of autonomy, competence, and relatedness, a 9-item Likert-type scale will be utilized (3 items per psychological need, anchors at 1 = Not at All and 7 = Extremely).
on average 2 days after interview
Treatment Evaluation
Time Frame: on average 2 days after interview
Participants will be asked a series of questions regarding their experience during the interview.
on average 2 days after interview

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
New York Blood Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-X-331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data may be obtained after data collection is completed. Individual participant data requests should be directed to the Principal Investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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